Synopsis

This educational presentation will show the path to obtaining regulatory clearance using examples from a startup company making a new type of Magnetic Resonance Imaging system. The novelty of the system design, accessories, software tools, use cases and technology provide a range of interesting regulatory challenges and ultimately solutions.

Syllabus topics

• Point-of-care MRI as a first-of-its-kind of medical imaging device. What are the similarities and difference to existing medical imaging devices?
• How do you even go about getting regulatory clearance¹
• Regulations, Laws, Directives, Standards, Guidances
• It takes a village: building the company prior to regulatory filing
• Demonstrating safety and effectiveness. It's all about risk, risk, risk & risk.
• What are verification and validation?
  
• The premarket submission process and the magic words: "You may, therefore, market the device"
• Follow-on submissions and geographical expansion: MDSAP, CE, UKCA
• Deep learning and Artificially Intelligent algorithms
• Post-market surveillance and adverse events²

Acknowledgements

References

1. US FDA. "How to Study and Market Your Device". https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device. Accessed 08/04/2022.
2. Delfino JG, Krainak DM, Flesher SA, Miller DL. MRI-related FDA adverse event reports: a 10-yr review. Med Phys. 2019;46:5562-5571.